Trial · NCT02609984
Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002)
NCT02609984, Phase 2, Terminated, Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA); results first posted 2020-05-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002). Trials, record NCT02609984. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02609984
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Compare the Safety and Efficacy of CMB305 With Atezolizumab to Atezolizumab Alone in Participants With Sarcoma (IMDZ-C232/V943A-002)
- NCT number
- NCT02609984
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 89 participants, actual
- Lead sponsor
- Immune Design, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Conditions
- Sarcoma, Myxoid/Round Cell Liposarcoma, Synovial Sarcoma, Metastatic Sarcoma, Recurrent Adult Soft Tissue Sarcoma, Locally Advanced Sarcoma, Liposarcoma
- Interventions
- CMB305, atezolizumab
- First posted
- 2015-11-20
- Last updated
- 2020-07-07
- Results first posted
- 2020-05-14
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 36.1 months | PFS was defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurred first, per RECIST 1.1 modified to use immune-related response criteria (irRC) confirmation and unidimensional tumor measurements as assessed by Blinded Independent Central Review (BICR). PD was defined as ≥20% increase in tumor burden compared with nadir (at any single time point) in 2 consecutive observations ≥4 weeks apart. If there was no disease progression or death, participants were censored at the date of their last disease assessment. The PFS was analyzed using the product-limit (Kaplan-Meier) method for censored data. |
| Primary | Overall Survival (OS) | Up to approximately 36.1 months | OS was determined for all participants and was defined as the time from randomization to death due to any cause. Participants were censored at the date of their last follow-up. The OS was analyzed using the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | Number of Participants Experiencing a Dose-Limiting Toxicity (DLT) | Up to approximately 42 days | DLTs will be evaluated during the safety run-in period. Any treatment emergent Grade 3 or higher adverse event (AE) that occurs in the first 42 days after initiation of study treatment, that is deemed possibly, probably or definitely related to the combination of CMB305 and atezolizumab will be considered a DLT with the following exceptions: * Alopecia or vomiting (unless not controlled by optimal anti-emetics) * Hepatic enzyme elevations associated with the baseline Grade 2 abnormalities * Grade 3 laboratory AEs that are asymptomatic and return to baseline or to Grade 1 within 3 days, unless identified specifically as DLT by the investigator or the Data Monitoring Committee (DMC) * Grade 3 fatigue * Grade 3 systemic reactions (such as fever, headache, influenza like symptoms, myalgia, malaise, or nausea) that return to baseline or Grade 1 within 3 days of study inoculation |
| Secondary | Number of Participants Who Experienced At Least One Adverse Event (AE) | Up to approximately 36.1 months | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who experienced at least one AE is presented. |
| Secondary | Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | Up to approximately 24 months | An AE was defined as any untoward medical occurrence in a participant administered a study treatment and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of study treatment, was also an AE. The number of participants who discontinued study treatment due to an AE is presented. |
| Secondary | Progression-Free Survival (PFS) Rate at Month 3 Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Month 3 | PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurred first, per RECIST 1.1 modified to use irRC confirmation and unidimensional tumor measurements as assessed by BICR. PD was defined as ≥20% increase in tumor burden compared with nadir (at any single time point) in 2 consecutive observations ≥4 weeks apart. If there was no disease progression or death, participants were censored at the date of their last disease assessment. The PFS was analyzed using the product-limit (Kaplan-Meier) method for censored data. Participants were evaluated every 6 weeks with radiographic imaging to assess their response to treatment. The PFS rate was calculated as the percentage of participants with PFS at Month 3. |
| Secondary | Progression-Free Survival (PFS) Rate at Month 6 Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Month 6 | PFS was defined as the time from randomization to the first documented PD or death due to any cause, whichever occurred first, per RECIST 1.1 modified to use irRC confirmation and unidimensional tumor measurements as assessed by BICR. PD was defined as ≥20% increase in tumor burden compared with nadir (at any single time point) in 2 consecutive observations ≥4 weeks apart. If there was no disease progression or death, participants were censored at the date of their last disease assessment. The PFS was analyzed using the product-limit (Kaplan-Meier) method for censored data. Participants were evaluated every 6 weeks with radiographic imaging to assess their response to treatment. The PFS rate was calculated as the percentage of participants with PFS at Month 6. |
| Secondary | Time to Next Treatment (TTNT) | Up to approximately 36.1 months | TTNT was the time from date of randomization to the start date of subsequent treatment. Participants were treated for up to approximately 2 years and then followed until next treatment or death. Participants who did not receive subsequent treatment were censored at the date of last contact or death. The TTNT was analyzed using the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | Distant Metastasis Free Survival (DMFS) | Up to approximately 36.1 months | DMFS was the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. Participants without metastasis and death were censored at the date of last contact or death. The DMFS was analyzed using the product-limit (Kaplan-Meier) method for censored data. |
| Secondary | Number of Participants Positive for Anti-New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) Antibody at Baseline | Baseline (Day 1) | The number of participants with anti-NY-ESO-1 antibodies at baseline was measured using an enzyme-linked immunosorbent assay (ELISA) with recombinant NY-ESO1 protein. A titer of \>1:100 was considered positive. The number of participants that were anti-NY-ESO-1 antibody positive at baseline is presented. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Up to approximately 36.1 months | The analysis population included all randomized participants who met eligibility criteria for the study and had data recorded in the electronic Case Report Form (eCRF). Participants were included in the treatment group to which they were randomized. | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) | Up to approximately 36.1 months | The analysis population included all randomized participants who met eligibility criteria for the study and had data recorded in the eCRF. Participants were included in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Number of Participants Experiencing a Dose-Limiting Toxicity (DLT) | Up to approximately 42 days | The analysis population included all participants who participated in the safety run-in period and received ≥1 dose of any of the CMB305 components (LV305, G305) or atezolizumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Experienced At Least One Adverse Event (AE) | Up to approximately 36.1 months | The analysis population included all participants who received ≥1 dose of any of the CMB305 components (LV305, G305) or atezolizumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | Up to approximately 24 months | The analysis population included all participants who received ≥1 dose of any of the CMB305 components (LV305, G305) or atezolizumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression-Free Survival (PFS) Rate at Month 3 Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Month 3 | The analysis population included all randomized participants who met eligibility criteria for the study and had data recorded in the eCRF. Participants were included in the treatment group to which they were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival (PFS) Rate at Month 6 Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Month 6 | The analysis population included all randomized participants who met eligibility criteria for the study and had data recorded in the eCRF. Participants were included in the treatment group to which they were randomized. | Percentage of participants | NUMBER |
| SECONDARY | Time to Next Treatment (TTNT) | Up to approximately 36.1 months | The analysis population included all participants who received ≥1 dose of any of the CMB305 components (LV305, G305) or atezolizumab. | Months | MEDIAN |
| SECONDARY | Distant Metastasis Free Survival (DMFS) | Up to approximately 36.1 months | The analysis population included all randomized participants who met eligibility criteria for the study and had data recorded in the eCRF. Participants were included in the treatment group to which they were randomized. | Months | MEDIAN |
| SECONDARY | Number of Participants Positive for Anti-New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) Antibody at Baseline | Baseline (Day 1) | The analysis population included all participants who received ≥1 dose of any of the CMB305 components (LV305, G305) or atezolizumab and had data available for baseline antibody analysis. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 2.6 | 95% Confidence Interval 1.4 to 2.9 | Months | |
| Progression-Free Survival (PFS) Per Modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) | Atezolizumab | 1.6 | 95% Confidence Interval 1.5 to 2.7 | Months | |
| Overall Survival (OS) | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 18.2 | 95% Confidence Interval 10.1 to 22.1 | Months | |
| Overall Survival (OS) | Atezolizumab | 18.0 | 95% Confidence Interval 15.3 to 26.5 | Months | |
| Number of Participants Experiencing a Dose-Limiting Toxicity (DLT) | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 1 | Participants | ||
| Number of Participants Experiencing a Dose-Limiting Toxicity (DLT) | Atezolizumab | 1 | Participants | ||
| Number of Participants Who Experienced At Least One Adverse Event (AE) | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 44 | Participants | ||
| Number of Participants Who Experienced At Least One Adverse Event (AE) | Atezolizumab | 43 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 6 | Participants | ||
| Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | Atezolizumab | 6 | Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 45 | |
| Overall Study | STARTED | Atezolizumab | 44 | |
| Overall Study | Treated | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 45 | |
| Overall Study | Treated | Atezolizumab | 43 | |
| Overall Study | COMPLETED | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 1 | |
| Overall Study | COMPLETED | Atezolizumab | 5 | |
| Overall Study | NOT COMPLETED | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 44 | |
| Overall Study | NOT COMPLETED | Atezolizumab | 39 |
Source ClinicalTrials.gov
Adverse events154
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 4 | 45 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Atezolizumab | 6 | 43 | 7 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 3 | 45 | 3 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Atezolizumab | 0 | 43 | 0 |
| other | Sinus tachycardia | Cardiac disorders | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 3 | 45 | 3 |
| other | Sinus tachycardia | Cardiac disorders | Atezolizumab | 1 | 43 | 1 |
| other | Constipation | Gastrointestinal disorders | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 9 | 45 | 10 |
| other | Constipation | Gastrointestinal disorders | Atezolizumab | 5 | 43 | 6 |
| other | Diarrhoea | Gastrointestinal disorders | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 12 | 45 | 15 |
| other | Diarrhoea | Gastrointestinal disorders | Atezolizumab | 7 | 43 | 11 |
1 to 10 of 154Source ClinicalTrials.gov
See all 154 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 31 | 45 |
| Total, all-cause mortality | Atezolizumab | 27 | 44 |
| Total, other adverse events | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 42 | 45 |
| Total, other adverse events | Atezolizumab | 42 | 43 |
| Total, serious adverse events | CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab | 17 | 45 |
| Total, serious adverse events | Atezolizumab | 9 | 43 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34260265 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons9
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab vs Atezolizumab: Number of Participants Positive for Anti-New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) Antibody at Baseline | Trial comparisons |
| CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab vs Atezolizumab: Number of Participants Experiencing a Dose-Limiting Toxicity (DLT) | Trial comparisons |
CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab vs Atezolizumab: Number of Participants Positive for Anti-New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) Antibody After Induction With Treatment | Trial comparisons |
| CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab vs Atezolizumab: Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE) | Trial comparisons |
CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab vs Atezolizumab: Number of Participants Positive for Anti-New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) T Cells After Induction With Treatment | Trial comparisons |
| CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab vs Atezolizumab: Number of Participants Who Experienced At Least One Adverse Event (AE) | Trial comparisons |
| CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab vs Atezolizumab: deaths from any cause | Trial comparisons |
| CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab vs Atezolizumab: Number of Participants Positive for Anti-New York Esophageal Squamous Cell Carcinoma-1 (NY-ESO-1) T Cells at Baseline | Trial comparisons |
| CMB305 (Sequentially Administered LV305 and G305)+Atezolizumab vs Atezolizumab: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
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GET https://conductscience.org/api/trials/v1/NCT02609984/results?page=2